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Safety and Efficacy Study of a Novel Hemostatic Tourniquet Device for Forearm Application

Safety and Efficacy Study of a Novel Hemostatic Tourniquet Device for Forearm Application

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101169
Enrollment
Unknown
Registered
2025-04-21
Start date
2021-01-12
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Limb surgery requiring exsanguination and hemostasis

Interventions

Sponsors

Cixi People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 60 years; 2. Blood pressure and heart rate within the normal range as defined by the Chinese Hypertension Guidelines; 3. BMI between 20 and 30; 4. Mid-upper forearm circumference between 24 and 40 cm; 5. Voluntary participation in the study; 6. Expected surgery duration within 90 minutes.

Exclusion criteria

Exclusion criteria: 1. Open distal radius fractures or pathological fractures; 2. Concurrent ipsilateral ulnar fractures requiring surgical treatment; 3. Mid-upper forearm circumference 40 cm; 4. Patients with thromboangiitis obliterans, venous thrombosis, severe arteriosclerosis, or other vascular diseases in the affected limb; 5. Patients with severe skin damage, limb infections, or malignant tumors; 6. Patients who have previously experienced severe discomfort, such as cardiac risk or respiratory distress, due to the use of hemostatic devices; 7. Preoperative systolic blood pressure that cannot be stably controlled below 180 mmHg.

Design outcomes

Primary

MeasureTime frame
Preoperative exsanguination and hemostasis time;intraoperative blood loss;tourniquet-related complications;

Secondary

MeasureTime frame
tourniquet time;surgery duration;hemostatic effectiveness in the surgical field;

Countries

China

Contacts

Public ContactBinbin Sun

Department of Orthopedics, Cixi People's Hospital

434600908@qq.com+86 159 8864 3874

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026